Data Management Programmer (SDTM)

About the role

This role sits within a dedicated sponsor team at IQVIA and works directly with the client to manage database and CRF-related activities and oversee SDTM deliverables across the study lifecycle. It is open to remote work from several European countries and South Africa. The position suits someone with a technical mindset, strong communication skills and a good understanding of SDTM.

Key responsibilities

• Provide end-to-end oversight of SDTM activities, including managing CRF design based on study protocols and ensuring vendor specifications match SDTM requirements
• Collaborate with Sponsor colleagues and CRO partners to review CRF design and compliance with standards and SDTM
• Work with Study Data Leads to plan data receipt and oversee it throughout assigned clinical trials
• Program reports and help standardise the reports used by external partners and vendors and internal teams
• Complete formal and ad-hoc analyses and oversee SDTM data
• Review critical documents such as SDTM annotations and datasets to ensure data standards are applied consistently and to support creation of the DE dataset
• Map SDTM data and manage annotated CRFs
• Attend meetings with Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST) and Early Phase
• Perform quality checks and create standard edit checks for new CRF modules
• Support audits and inspections and other projects assigned by the company

Required profile

• At least 5 years of relevant experience in SDTM oversight and/or CRF design
• Prior experience in a clinical or pharmaceutical field
• Prior experience in a Data Management field
• Advanced knowledge of GCP and Good Clinical Data Management Practices
• Excellent spoken and written English

Required skills

• Biometrics processes: reviewing SDTM annotated CRFs, writing and reviewing technical specifications, reviewing log files and troubleshooting errors
• Data mapping and SDTM Controlled Terminology
• Relational databases, preferably Clinical Data Management and EDC systems
• Advanced familiarity with reporting tools
• SAS programming and SDTM deliveries are an added value